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EC number: 258-004-5 | CAS number: 52556-42-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14. November 2012 - 18. december 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
- EC Number:
- 258-004-5
- EC Name:
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
- Cas Number:
- 52556-42-0
- Molecular formula:
- C6H12O5S.Na
- IUPAC Name:
- sodium 2-hydroxy-3-(prop-2-en-1-yloxy)propane-1-sulfonate
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
- Reference substance name:
- 3-(allyloxy)propane-1,2-diol
- EC Number:
- 204-620-4
- EC Name:
- 3-(allyloxy)propane-1,2-diol
- Cas Number:
- 123-34-2
- Molecular formula:
- C6H12O3
- IUPAC Name:
- 3-(allyloxy)propane-1,2-diol
- Reference substance name:
- disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate
- Molecular formula:
- C6H12Na2O8S2
- IUPAC Name:
- disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate
- Test material form:
- solid - liquid: aqueous solution
- Details on test material:
- light yellow liquid
Constituent 1
additive 1
impurity 1
impurity 2
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Species fresh bovine corneas
Origin
Fresh bovine eyes were obtained from the slaughterhouse on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank’s balanced salt solu-tion (supplemented with 0.01% streptomycin and 0.01% penicillin). Then the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 hour.
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- Post incubation: 2 hours at 32 °C.
- Number of animals or in vitro replicates:
- For each treatment group (negative control, positive control and test item), three replicates were used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 150.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Opacity and Permeability Values
The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Absorption and Opacity Values Negative Control
Parameter |
Negative Control |
||
Absorption before exposition |
0.1826 |
0.1843 |
0.1736 |
Absorption after exposition |
0.2772 |
0.2472 |
0.1824 |
Opacity before exposition |
1.5226 |
1.5286 |
1.4914 |
Opacity after exposition |
1.8932 |
1.7669 |
1.5219 |
Opacity difference |
0.3706 |
0.2382 |
0.0305 |
Mean opacity difference of the negative control is 0.2131.
Absorption and Opacity Values Test Item and Positive Control
Parameter |
Test Itemsodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) |
Positive Control |
||||
Absorption before exposition |
0.1623 |
0.1618 |
0.2444 |
0.1792 |
0.2138 |
0.1321 |
Absorption after exposition |
2.0500 |
2.1496 |
2.1244 |
2.2342 |
1.9648 |
2.1006 |
Opacity before exposition |
1.4531 |
1.4514 |
1.7555 |
1.5108 |
1.6361 |
1.3555 |
Opacity |
112.2018 |
141.1237 |
133.1680 |
171.4747 |
92.2147 |
126.0666 |
Opacity |
110.7487 |
139.6723 |
131.4125 |
169.9639 |
90.5786 |
124.7111 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
Optical density at 490 nm
Repl. |
Negative Control |
Test Itemsodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) |
Positive Control |
||||||
Meas. |
0.0101 |
0.0106 |
0.0059 |
0.3672 |
0.2928 |
0.2957 |
0.3771 |
0.3820 |
0.3852 |
Corr. |
0.0505 |
0.0530 |
0.0295 |
1.8360 |
1.4640 |
1.4785 |
1.8855 |
1.9100 |
1.9260 |
Mean |
0.0443 |
-- |
*In order to correct the path length, a factor of 5 was taken into account when calculating the IVIS
IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
1.128 |
0.878 |
40.3% |
1.033 |
|||
0.473 |
|||
Test Item |
137.411 |
150.293 |
7.9% |
160.755 |
|||
152.712 |
|||
Positive Control |
197.369 |
156.148 |
25.4% |
118.351 |
|||
152.723 |
This in vitro study was performed to assess the corneal irritation and damage potential of sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test itemsodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS)was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32±1 °C for one hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutesat32±1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control, sodium hydroxide (10% solution in 0.9% sodium chloride solution) was used as positive control.
The positive control induced a very severe irritation on the cornea, mean IVIS was 156.148.
The negative control showed no irritation, mean IVIS was 0.878.
The test item was tested pure. A mean IVIS of 150.293 was calculated, corresponding to an ICCVAM classification as very severely eye irritant. According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant. Therefore,sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) is classified as “corrosive” and/or “eye irritant”.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant. Substances with IVIS < 55.1 may be considered as non-corrosive resp. not severely irritant.
In the negative control, no signs of eye irritation were observed.
The positive control showed very severe eye irritation.
The test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) showed very severe eye irritation.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test itemsodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) possesses very severe eye irritation potential (according to ICCVAM).
According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.
Therefore, according to OECD, sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS)is classified as “corrosive” and/or “severe irritant”. - Executive summary:
One valid experiment was performed.
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32±1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32±1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.
10% sodium hydroxide solution was used as positive control. The positive control induced a severe irritation on the cornea.
The test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) showed very severe effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 150.293.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) possesses very severe eye irritation potential (according to ICCVAM).
According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.
Therefore, according to OECD,sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) is classified as “corrosive” and/or “severe irritant”.
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